Intraocular lens injector assembly having shuttle assembly retaining intraocular lens in storage vial and operably presenting intraocular lens in injector assembly

ABSTRACT

A shuttle, vial and injector are provided for storing and presenting an IOL to a patient. The shuttle includes operably engaged shuttle plates having a set of confronting surfaces that flex about a flexure interface between a storage configuration, with at least an optic of an IOL in a nominal state and a loading configuration, with at least an optic of an IOL in a deformed state. The vial engages the shuttle and maintains the shuttle in the storage configuration. The injector receives the shuttle from the vial and includes surfaces for flexing the portions of the shuttle plates to the loading configuration upon engagement with the injector, wherein the shuttle plates impart a predetermined curvature to at least a portion of the IOL.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

REFERENCE TO A “SEQUENCE LISTING”

Not applicable.

BACKGROUND OF THE INVENTION Field of the Invention

The present disclosure relates to storing and presenting an intraocularlens (IOL) to a patient, and particularly to a kit having a shuttle, avial and an injector, and more particularly to a shuttle that ismoveable between an engaged IOL retaining storage configuration and anengaged IOL retaining loading configuration, wherein the vial interactswith the shuttle to dispose the shuttle in the storage configuration inwhich the IOL is retained in a nominal state and the injector interactswith the shuttle to dispose the shuttle in the loading configuration, inwhich at least a portion of the IOL retained in the shuttle ispreferentially biased or deformed.

Description of Related Art

Intraocular lenses (also referred to herein as IOLs or simply as lenses)are artificial lenses used to replace natural crystalline lenses of eyeswhen the natural lenses are diseased or otherwise impaired. Under somecircumstances a natural lens may remain in an eye together with animplanted IOL. IOLs may be placed in either the posterior chamber or theanterior chamber of an eye.

IOLs come in a variety of structures and materials. Various instrumentsand methods for implanting such IOLs in an eye are known. Typically, anincision is made in a cornea and an IOL is inserted into the eye throughthe incision. In one technique, a surgeon uses surgical forceps to graspthe IOL and insert it through the incision into the eye. While thistechnique is still practiced today, more and more surgeons are using IOLinjectors which can offer advantages such as affording a surgeon morecontrol when inserting an IOL into an eye and permitting insertion ofIOLs through smaller incisions. Smaller incision sizes (e.g., less thanabout 3 mm) are preferred over larger incisions (e.g., about 3.2 to 5+mm) since smaller incisions have been associated with to reducedpost-surgical healing time and reduced complications such as inducedastigmatism.

In order for an IOL to fit through a smaller incision, the IOL istypically folded and/or compressed prior to entering an eye where itwill assume its original unfolded/uncompressed shape. Since IOLs arevery small and delicate articles of manufacture, great care must betaken in their handling, both as they are loaded into an injector and asthey are injected into the eye.

It is important that an IOL be expelled from the tip of the IOL injectorand into the eye in an undamaged condition and in a predictableorientation. Should an IOL be damaged or expelled from the injector inan incorrect orientation, a surgeon must remove or further manipulatethe IOL in the eye, possibly resulting in trauma to the surroundingtissues of the eye. To achieve proper delivery of an IOL, consistentloading of the IOL into the injector with a minimum opportunity fordamaging the IOL is desirable.

Various IOL injectors and other devices have been proposed which attemptto address issues related to loading and presenting the IOL to thepatient, yet there remains a need for a shuttle, vial and injectorassembly which eliminates the need for operator handling of the IOL andthereby reduces the likelihood of damage to the IOL prior topresentation to a patient.

BRIEF SUMMARY OF THE INVENTION

The present disclosure provides a shuttle for retaining an IOL having anoptic, the shuttle having a first shuttle plate and a separate secondshuttle plate operably coupled and then configurable between a coupledstorage configuration and a coupled loading configuration, the first andthe second shuttle plates in each of the coupled storage configurationand the coupled loading configurations defining an IOL chamber extendingalong a longitudinal axis, the IOL chamber axially bounded by a proximalport and a distal port, wherein each of the proximal port and the distalport in each of the coupled storage configuration and the coupledloading configurations has a major dimension transverse to thelongitudinal axis, the major dimension being smaller than a diameter ofthe optic.

The present disclosure further provides a shuttle for retaining an IOLhaving an optic, the shuttle including a first shuttle plate and aseparate second shuttle plate configured to operably engage the firstshuttle plate, such that the operably engaged first and second shuttleplates are configured to be disposed between an engaged storageconfiguration and an engaged loading configuration; wherein the operablyengaged first and second shuttle plates define a shuttle having (i) ashuttle lumen extending along a longitudinal axis, the shuttle lumenhaving an IOL chamber sized to retain an optic of an IOL, (ii) a storageset of confronting surfaces, (iii) a loading set of confronting surfacesand (iv) a flexure interface intermediate the storage set of confrontingsurfaces and the loading set of confronting surfaces, wherein theoperably engaged first and second shuttle plates contact the storage setof confronting surfaces in each of the engaged storage configuration andthe engaged loading configuration, and the loading set of confrontingsurfaces flex from being spaced apart in the engaged storageconfiguration of the operably engaged first and second shuttle plates toabutting in the engaged loading configuration of the operably engagedfirst and second shuttle plates.

Also disclosed is a method of disposing an IOL having an optic within ashuttle, the method including the steps of capturing an IOL whilelocated on a fixture within an IOL chamber defined by an engaged firstshuttle plate and second shuttle plate, the engaged first shuttle plateand a second shuttle plate defining a shuttle; and withdrawing thefixture from the IOL through a port in the IOL chamber to retain the IOLwithin the IOL chamber defined by the engaged first shuttle plate andsecond shuttle plate.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

FIG. 1 is an exploded view of a shuttle, vial, a lid and an IOl, whereinthe shuttle retains the IOL and the vial and lid retain the shuttle.

FIG. 2 is a perspective view of the components shown in FIG. 1 in anassembled or storage configuration.

FIG. 3a is a perspective view of the shuttle shown in FIG. 1 in astorage configuration.

FIG. 3b is a perspective view of the shuttle shown in FIG. 1 in aloading configuration.

FIG. 4 is an enlarged perspective view of a portion of the vial showingengagement surfaces.

FIG. 5 is a cross sectional view of the shuttle and the IOL in thestorage configuration as retained in the vial.

FIG. 6 is a perspective, cross sectional view of the shuttle and the IOLin the storage configuration as retained in the vial.

FIG. 7 is a top plan view of a cross sectional of the shuttle and theIOL in the storage configuration as retained in the vial.

FIG. 8 is a perspective view of the shuttle operably engaged with aninjector.

FIG. 9 is a perspective view of a plunger assembly of the injector.

FIG. 10 is a perspective view of the shuttle operably engaged with aninjector.

FIG. 11 is a cross sectional view of the shuttle and the IOL in theloading configuration as retained in the injector.

FIG. 12 is a perspective, cross sectional view of the shuttle and theIOL in the loading configuration as retained in the injector.

FIG. 13 is an exploded perspective view of the IOL in the shuttle in theloading configuration.

FIG. 14 is a perspective, cross sectional view of the IOL and a portionof the shuttle in the loading configuration as retained in the injector.

FIG. 15 is an enlarged perspective, cross sectional view of the IOL anda portion of the shuttle in the loading configuration as retained in theinjector.

FIG. 16 is an enlarged perspective, cross sectional view of the IOL anda portion of the shuttle in the loading configuration as retained in theinjector with the plunger assembly advanced.

DETAILED DESCRIPTION OF THE INVENTION

Generally, the present disclosure provides for a kit having a shuttle100, a vial 200, and an injector 300, wherein the shuttle retains andstores an IOL 10, the vial retains the shuttle and the injector injectsthe IOL along a longitudinal axis into an eye of a patient.

As used herein, an IOL 10 is an artificial lens used to replace thenatural crystalline lens of the eye when the natural lens has cataractsor is otherwise diseased. IOLs 10 are also sometimes implanted into aneye to correct refractive errors of the eye in which case the naturallens may remain in the eye together with the implanted IOL. The IOL 10may be placed in either the posterior chamber or anterior chamber of theeye. IOLs 10 come in a variety of structures and materials. Some commonIOL 10 styles include the so-called open-looped haptics which includethe three-piece type having an optic and two haptics 12, 14 attached toand extending from an optic 16; the one-piece type wherein the optic andhaptics are integrally formed (e.g., by machining the optic and hapticstogether from a single block of material); and also the closed loopedhaptic IOLs. A further style of IOL is called the plate haptic typewherein the haptics are configured as a flat plate extending fromopposite sides of the optic. The IOL 10 may be made from a variety ofmaterials or combination of materials such as, but not limited to PMMA,silicone, hydrogels and silicone hydrogels.

It is also understood that the IOL 10 structure shown and describedherein is for discussion purposes only, and that the present inventionis not to be limited by the particular structure of the IOL. The presentsystem may be easily adapted to IOLs 10 of any structure and type (e.g.,IOLs with plate, open or closed loop haptics, anterior chamber IOLs,posterior chamber IOLs, accommodating IOLs (including single and doublelens types), etc.). The IOL 10 has a nominal state in the absence ofexternal forces (other than gravity). That is, the nominal state is theformation the IOL assumes upon the removal of deforming forces.

Vial

Referring to FIG. 1, the vial 200 is sized to retain the shuttle 100,wherein the shuttle retains the IOL 10. The vial 200 can include a lid202 for sealing the vial from an ambient environment. The vial 200 issized to retain the shuttle 100 and IOL 10 along with a volume ofsterile or sterilizing solution (not shown). Typically, the sterilesolution is retained in the sealed vial 200 with the shuttle 100 and theIOL 10 to maintain the IOL in a sterile, liquid environment untilintended use.

As seen in FIG. 2, the shuttle 100 is coupled to the vial 200 topreclude unintended separation, wherein the lid 202 seals the vial withthe shuttle and IOL inside. Referring to FIGS. 4-6, the vial 200includes (i) orienting and locating surfaces 210 for orienting theshuttle in the vial, (ii) locating surfaces 220 for locating the IOLwithin the shuttle and (iii) wedging surfaces 230 to dispose the shuttlein the storage configuration. It is understood, these surfaces can beseparate spaced surfaces of the vial 200 or can be incorporated intocommon surfaces performing a plurality of functions.

The orienting surfaces 210 are configured as elongate ribs for frictionfitting with a surface of the shuttle 100, and typically an outersurface of the shuttle. The orienting surfaces 210 function to orientand constraint the shuttle 100 is a predetermined relationship withinthe vial 200. Further, the orienting surfaces 210 can be sized toprovide a friction fit engagement with the shuttle 100 to assist inretaining the shuttle relative to the vial 200.

The locating surfaces 220 are configured to be disposed within a portionof the shuttle 100 upon the shuttle being operably engaged with the vial200. The locating surfaces 220 bound or limit movement of the IOL 10within the shuttle 100. As seen in FIGS. 2, 6 and 7, the locatingsurfaces 220 project into the shuttle 100 to limit or bound movement ofthe IOL 10 within the shuttle upon operable engagement of the shuttlewith the vial 200.

The wedging surfaces 230 of the vial 200 are configured to urge or forcethe shuttle 100 to a storage configuration, such as the engaged orcoupled storage configuration, upon operable engagement of the shuttleand the vial.

The lid 202 seals the vial 200 by any of a variety of mechanisms knownin the art to retain the solution within the vial.

The surfaces of the vial 200 in conjunction with the lid are configuredto engage and retain the shuttle 100 relative to the vial so as topreclude unintended displacement of the shuttle and restrict the shuttlein the vial from compressing or deforming the IOL 10 during intendedstorage and transportation.

Thus, the vial 200 is constructed to engage, and dispose the shuttle 100to a storage configuration and retain the shuttle in the storageconfiguration, wherein an IOL optic 16 is maintained in a nominal,unstressed, state.

Shuttle

The shuttle 100 includes a first shuttle plate 120 and a second shuttleplate 160, wherein the first and the second shuttle plates areconfigured to operably engage and define (i) a shuttle lumen 102 havingan IOL chamber 104 sized to receive the IOL 10, (ii) a storage set ofconfronting surfaces 122, 162, (iii) a loading set of confrontingsurfaces 124, 164 and (iv) a flexure interface 126, 166 intermediate thestorage set of confronting surfaces and the loading set of confrontingsurfaces, such that portions of the operably engaged first and secondshuttle plates flex about the flexure interface between (a) a storageconfiguration, such as an engaged or coupled storage configuration,wherein the storage set of confronting surfaces abut and the loading setof confronting surfaces are spaced apart and (b) a loadingconfiguration, such as an engaged or coupled loading configuration,wherein both the storage set of confronting surfaces and the loading setof confronting surfaces abut. The terms storage configuration andloading configuration are intended to encompass engaged or coupledstorage configuration and engaged or coupled loading configuration,respectively.

As used in connection with the description of the engaged shuttle plates120, 160 flexing or moving between and assuming the differentarrangements or relative positions, the term configuration is intendedto encompass the different arrangements or relative positions of theshuttle plates, when the shuttle plates are flexed relative to eachother while engaged, as set forth below. Further, the term abut meansnext or adjacent to, having a common boundary or in contact.

As seen in FIG. 11, each shuttle plate 120, 160 includes a recess 130,170 defining a portion of the shuttle lumen 102 and the IOL chamber 104,a distal port 106 and a proximal port 108, shown in FIG. 14. The shuttlelumen 102 extends along the longitudinal axis. Referring to FIG. 11,each shuttle plate 120, 160 thus includes the corresponding storageconfronting surface 122, 162, the loading confronting surface 124, 164,and the flexure interface 126, 166.

Referring to FIGS. 15 and 16, each recess 130, 170 defining the portionof the IOL chamber 104 includes a haptic ramp 132, 172, therebydisposing the haptic ramp in the IOL chamber upon operable engagement ofthe shuttle plates 120, 160. The haptic ramp 132, 172 defines anincluded surface in the IOL chamber 104, wherein the haptic ramp isinclined along and relative to the longitudinal axis. In one embodiment,the incline of each haptic ramp 132, 172 locates an end of the rampsubstantially coplanar or above an adjacent portion of the optic 16 ofthe IOL 10 refrained in the shuttle 100. The incline is sufficient tocause at least a portion of each haptic 12, 14 to overlay the optic 16as the IOL 10 is urged by the injector 300 from the IOL chamber 104.Thus, each haptic ramp 132, 172 is located to contact a correspondinghaptic 12, 14 upon translation of the IOL 10 along the longitudinal axisin the shuttle lumen 102. As set forth below, movement of the IOL 10 inresponse to the injector can include a deformation or movement of thehaptics 12, 14 which causes the haptics to contact a correspondinghaptic ramp 132, 172, and upon further movement of the IOL 10 thehaptics travel up the ramps to the overlying position with respect forthe optic 16 of the IOL.

As seen in FIGS. 11 and 13, the storage confronting surface 122, 162 andthe loading confronting surface 124, 164 of each shuttle plate 120, 160extends the length of the shuttle plate along the longitudinaldirection. However, it is understood the storage confronting surface122, 162 and the loading confronting surface 124, 164 of each shuttleplate 120, 160 can effectively be reduced to half the length of theshuttle plate as well as to a point of contact between the first shuttleplate and the second shuttle plate.

In one embodiment of the shuttle plates 120, 160, the storage set ofconfronting surfaces 122, 162 are parallel and the loading set ofconfronting surfaces 124, 164 are nonparallel in the first or storageconfiguration in of the shuttle 100. In this embodiment of the shuttleplates 120, 160, the storage set of confronting surfaces 122, 162 remainparallel and the loading set of confronting surfaces 124, 164 are flexedto a parallel orientation in the second or loading configuration of theshuttle 100.

The flexure interface 126, 166 is the interface for the flexing orhinging of the shuttle plates 120, 160 and specifically pivoting theloading set of confronting surfaces 124, 164 relative to the storage setof confronting surfaces 122, 162. The flexure interface 126, 166 can bepoints of contact, a line of contact or contacting two-dimensionalareas. Referring to FIG. 11, the flexure interface 126, 166 is definedby surfaces that are intermediate the storage confronting surfaces 122,162 and the loading confronting surface 124, 164 of each shuttle plate120, 140 along a directional transverse to the longitudinal axis.

The flexure interface 126, 166 can provide for flexing of portions ofthe shuttle plates 120, 160 (and particularly the loading set ofconfronting surfaces 124, 164) about an axis, wherein the axis isgenerally parallel to the longitudinal axis. It is further understoodthe flexing of the shuttle plates 120, 160 can include a rockingmovement or relationship, wherein the movement is of an arcuate orconcave surface against another surface which can be arcuate, planar,concave or convex. Thus, rather than a line or axis of flexure, theflexing relationship can include movement along an area of the flexureinterface 126, 166.

Thus, along a direction transverse to the longitudinal axis, the flexureinterface 126, 166 or surface, is intermediate the storage set ofconfronting surfaces 122, 162 and the loading set of confrontingsurfaces 124, 164. Accordingly, the IOL chamber 104 is intermediate thestorage set of confronting surfaces 122, 162 and the loading set ofconfronting surfaces 124, 164 along a direction transverse to thelongitudinal axis.

Each shuttle plate 120, 160 also includes a retaining tab 128, 168moveable between a nominal, relaxed position and a flexed position. Theretaining tabs 128, 168 are configured to engage and lock in theinjector 300, and in one configuration preclude nondestructiveseparation of the shuttle 100 from the injector. Conversely, theengagement of the shuttle 100 and vial 200 is constructed to permitselectively disengagement of the shuttle from the vial. While eachshuttle plate 120, 160 is shown having two retaining tabs 128, 168, itis contemplated each shuttle plate can include one or three or moreretaining tabs. It has been found satisfactory for each shuttle plate120, 160 to include two longitudinally spaced retaining tabs 128, 168.

The first and the second shuttle plates 120, 160 also define an accessport 150, as shown in FIGS. 3a and 3b , used in loading the IOL 10within the shuttle 100. The access port 150 can be transverse to thelongitudinal axis of the shuttle lumen 102 and accesses or opens to theIOL chamber 104. The access port 150 has a major dimension, or diameter,which is less than the IOL 10 or at least the optic 16 of the IOL so asto substantially preclude passage of the IOL through the access portunder intended operating conditions. While the access port 150 is shownas independent of the distal port 106 and the proximal port 108, it isunderstood that depending on the construction of the fixture set forthbelow one of the distal port and the proximal port can function as theaccess port.

The shuttle plates 120, 160 further include an interconnect structurefor interconnecting the shuttle plates while allowing relative movement,such as flexing of the loading set of confronting surfaces 124, 164 ofthe shuttle plates between the storage configuration and the loadingconfiguration. Referring to FIGS. 3b and 11, in one embodiment of theinterconnect structure, each shuttle plate 120, 160 includes a receivinghole 134, 174 and a mating post 136, 176, wherein the receiving hole ofthe first shuttle plate 120 receives the mating post of the secondshuttle plate 160 and the receiving hole of the second shuttle platereceives the mating post of the first shuttle plate. This embodiment canfurther provide one of the mating posts such as 176 having flexiblecapture tabs 178 defined by adjacent gaps 179, wherein the length of themating post and thickness of the shuttle plate at the receiving hole areconfigured to provide that the capture tabs are flexed to a compressedstate to pass entirely through the hole and then expand to the relaxedstate, wherein the capture tabs are spaced from the outer surface of theshuttle plate, thereby allowing relative movement of the engaged orcoupled shuttle plates. Alternatively, the capture tabs are sized to belocated adjacent to or in contact with the outer surface of thereceiving shuttle plate, thereby retaining the storage set ofconfronting surfaces 122, 162 in an abutting orientation in both thestorage configuration and the loading configuration of the shuttle 100.By sizing the capture tabs 178 and amount of compression necessary topass through the receiving hole 134, passage of the capture tabs backthrough the receiving hole is precluded—thereby providing fornon-destructive separation of the coupled or engaged shuttle plates 120,160. That is, non-destructive separation of the engaged or coupledshuttle plates 120, 160 is precluded by configuring the capture tabs 178and the receiving hole 136, and the amount of compression necessary topass through the receiving hole. Alternatively, the shuttle plates 120,160 can be configured to permit non-destructive separation.

The remaining mating post and receiving hole, such as 136 and 174 areconfigured to function as a guide for the relative engagement of theshuttle plates 120, 160. That is, the remaining mating post andreceiving hole provide that the engaged shuttle plates 120, 160 can onlyflex about the flexure interface 126, 166 parallel to the longitudinalaxis. The engagement of the remaining post and receiving hole (i)prevent the engaged shuttle plates from spinning about the engagement ofthe first mating post and the first receiving hole and (ii) permitflexing of the portions of the shuttle plates 120, 160 about the flexureinterface 126, 166.

Referring to the FIGS. 3b and 11, the shuttle plates 120, 160 areoperably interconnected, such as engaged or coupled by aligning eachmating post 136, 176 with the respective receiving hole 134, 174 andpressing the shuttle plates together, thereby compressing the matingpost having the capture tabs to a cross section sufficiently small topass the mating post with the capture tabs through the correspondingreceiving hole of the remaining plate, until the capture tabs passthrough the corresponding shuttle plate, expand and couple or engage theshuttle plate. In the configuration of the capture tabs 178 being spacedfrom the outside surface of the shuttle plate receiving the tabs, theshuttle plates 120, 160 can be rocked, while in an engaged or coupledstate. In the configuration of the capture tabs 178 contacting theoutside surface of the receiving shuttle plate, the storage set ofconfronting surfaces 122, 162 are retained in an abutting relationshipin each configuration of the shuttle 100, as shown in FIGS. 3a and 5.The remaining mating post and corresponding receiving hole such as 136and 174 guide the relative motion of the shuttle plates 120, 160 aboutthe flexure interface. The engagement or coupling of the shuttle plates120, 160 includes the connection or interconnection of the otherwiseseparate components to form the operable shuttle 100.

The first and the second shuttle plates 120, 160 are separateindependent elements. That is, the shuttle plates 120, 160 are notjoined or connected prior to their engagement to form the shuttle 100.There is no integral connection of the shuttle plates 120, 160 beforethe individual shuttle plates are interconnected to form the shuttle100. The shuttle plates 120, 160 being independent means the shuttleplates are separate elements which are interconnected, such as by beingcoupled or engaged, only as part of the assembling or formation of theshuttle 100. It is contemplated the first and the second shuttle plates120, 160 are individually formed and form the IOL chamber 104 only uponcoupling or engagement of the separate shuttle plates. Thus, the termseparate means discrete, independent components that are not integrallyconnected or joined.

Upon operable engagement or coupling of the shuttle plates 120, 160, theresulting shuttle 100 defines the shuttle lumen 102 having the IOLchamber 104 for retaining the IOL 10, wherein the IOL chamber is boundedalong the longitudinal axis by the proximal port 108 and the distal port106. The haptic ramps 132, 172 are thus located in the IOL chamber 104.By retaining the IOL 10, the IOL chamber 104 forms a container thatcaptures the IOL, wherein the IOL cannot pass from the chamber in anydirection without deformation from a nominal state, and in selectembodiments without deformation of the optic 16 of the IOL. In selectembodiments, the IOL chamber 104 is entirely defined by the first andthe second shuttle plates 120, 160.

The distal port 106 and the proximal port 108 are sized to pass aportion of the injector 300. In one embodiment, the distal port 106 andthe proximal port 108 define a continuous periphery, wherein theperiphery of each port lies in a corresponding plane. However, as seenin the Figures, the periphery of each the distal port 106 and theproximal port 108 can extend along a dimension of the longitudinal axis.That is, the periphery of each of the distal port 106 and the proximalport 108 does not lie in a single plane, but rather extends a distancealong the longitudinal axis. In the loading configuration, at least thebottom of the shuttle lumen defines a substantially continuous surface.That is, the bottom is free of gaps or spacings between the shuttleplates that would detrimentally interfere with the movement of the IOL10 along and from the shuttle lumen. As the IOL 10 is preferentiallycurved along the bottom of the shuttle lumen, a top portion of the lumenat the proximal end need not be continuous. It is advantageous indeforming the IOL 10 to a presentation configuration that the distal endof the top of the shuttle lumen 102 be a sufficiently continuous surfaceto preclude detrimental engagement with the IOL as the IOL passes thedistal port.

The distal port 106 and the proximal port 108 have a major dimensiontransverse to the longitudinal axis. As seen in the FIGS. 5, 6 and 11,the distal port 106 and the proximal port 108 can have a non-circular,elliptical or oval cross section. In such embodiments, the majordimension is the largest dimension transverse to the longitudinal axiswhich is bounded by the periphery of the port.

As set forth above, the interconnection of shuttle plates 120, 160permits the relative flexing, or pivoting, of the loading set ofconfronting surfaces 124, 164 of the shuttle plates, while the shuttleplates remain in an interconnected, coupled or engaged, configuration.Specifically, with the engaged first and second shuttle plates 120, 160,the loading set of confronting surfaces 124, 164 can be flexed about theflexure interface between (i) a storage configuration, wherein thestorage set of confronting surfaces 122, 162 abut and the loading set ofconfronting surfaces 124, 164 are spaced apart and (ii) a loadingconfiguration, wherein the storage set of confronting surfaces remainabutting while the loading confronting surfaces are pivoted about theflexure interface to abut.

The IOL chamber 104, existing and defined and operable in both thestorage configuration of the shuttle 100 and the loading configurationof the shuttle, changes a dimension for retaining the IOL 10 as theshuttle is configured between the storage configuration and the loadingconfiguration. Specifically, the IOL chamber 104 defines (i) a storagedimension transverse to the longitudinal axis for the optic 16 of theIOL 10 in the storage configuration and (ii) a loading dimensiontransverse to the longitudinal axis for the optic of the IOL in theloading configuration, wherein the loading dimension is smaller than thestorage dimension. In one embodiment, the storage dimension issufficient to retain at least the optic 16 of the IOL 10 in a nominalstate. The loading dimension and surfaces defining the IOL chamber 104are selected such that upon the shuttle 100 being disposed in theloading configuration, the optic 16 of the IOL 10 is preferentiallydeformed or curved to a substantially predetermined shape.

Injector

The representative injector 300 is shown in FIG. 8. The injector 300includes an injector body 310 having a lumen 312, seen in FIGS. 15 and16, extending along the longitudinal axis from a proximal end to distalend. The lumen 312 can have any of a variety of cross-sectionalprofiles, wherein circular or oval shapes are typical. The proximal endof the injector body 310 may include a finger hold flange preferablyconfigured with an edge as shown for resting the injector on a flatsurface. It is understood that the overall structure of the injectorbody 310 may vary from that shown and described herein. It isfurthermore understood that the components of the injector 300 may bemade of any suitable material (e.g., polypropylene) and may be wholly orpartly opaque, transparent or translucent to better visualize the IOLwithin the injector device and the IOL delivery sequence.

In one embodiment, the injector body 310 further cooperates with aninjector tip 320 which defines an extension of the lumen so as to definea pathway of the IOL 10 from the shuttle 100 to the eye of the patient.The injector tip 320 defines a terminal end of a size for insertion orpresentation to the eye, with the IOL 10 correspondingly deformed withinthe injector tip. However, it is understood, the injector body 310 caninclude an integral injector tip or nozzle defining a portion of thelumen for directing the IOL 10 from the shuttle to the eye of thepatient.

Referring to FIGS. 10, 11, 12 and 14-16, the injector body 310 furtherincludes a shuttle bay 330 opening into the lumen 312. The shuttle bay330 receives or accepts the shuttle 100 for operable engagement with theinjector 300. The shuttle bay 330 includes engaging surfaces 332 forengaging the shuttle 100. The engaging surfaces 332 can includealignment surfaces for contacting the shuttle 100 in predeterminedlocations to provide accurate and reproducible retention of the shuttlein the injector 300.

The shuttle bay 330 also includes camming surfaces 334 that flex orpivot the loading set of confronting surfaces 124, 164 of the engagedshuttle plates 120, 160 from the storage configuration to the loadingconfiguration. As seen in FIGS. 11-13, upon being disposed in theloading configuration, the storage set of confronting surfaces 122, 162remain substantially as in the storage configuration and the loading setof confronting surfaces 124, 164 are flexed to abut.

The injector 100 is shown as employing a user imparted actuation forcefor moving the IOL 10 from the shuttle 100 and into the eye.

Referring to FIGS. 8-10 and 15, 16, the injector 100 includes a plunger340 having a plunger shaft 342 and a plunger tip 344 configured forengaging the IOL 10 and specifically the optic 16 at the periphery ofthe optic as the plunger is advanced along the shuttle lumen 102. It isunderstood that other plunger tip designs may be used with the presentsystem as desired. In one embodiment, the plunger shaft 342 isrotationally fixed within lumen 312 to prevent unexpected rotation ofthe plunger shaft (and thus the plunger tip) with the lumen. The plungershaft 342 may be rotationally fixed by forming the proximal shaft lengthand lumen non-circular in cross-section or by including rotationalfixing elements on the lumen inner wall and plunger shaft (e.g.,longitudinal flange on the plunger having a sliding fit within alongitudinally extending groove provided on the lumen inner wall).

Operation

After manufacture of the IOL 10, the IOL is releasably retained on afixture. The fixture can be any of a variety of constructions that canretain and repeatedly locate an IOL 10 without damage to the IOL. In oneembodiment, the fixture is a mount fixed at an end of an elongate shaft,wherein the mount and a portion of the elongate shaft can be passedthrough the access port 150 of the shuttle 100. The orientation of themounted IOL can be aby of a variety of orientations, such as but notlimited to orienting the IOL 10 such that an optical axis of the IOL isperpendicular to or parallel to the shuttle lumen 102.

As the IOL 10 is retained on the fixture, the first shuttle plate 120and the second shuttle plate 160 are brought together andinterconnected, such as engaged or coupled, about the retained IOL so asto form the IOL chamber 104 about the retained IOL, wherein the aportion of the fixture is disposed within the access port 150. As theshuttle plates 120, 160 are engaged as set forth above, therebycapturing the IOL 10 in the IOL chamber 104, the IOL is released fromthe fixture and the fixture is withdrawn through the access port 150,leaving the IOL retained in the shuttle 100.

In one configuration, the IOL 10 is oriented within the IOL chamber 104such that one haptic 12 is adjacent or towards the distal port 106thereby defining a leading haptic and the remaining haptic 14 isadjacent or towards the proximal port 108 thereby defining a trailinghaptic as oriented within the IOL chamber 104 of the shuttle 100.

When the shuttle 100 is unconstrained in either the vial 200 or theinjector 300, the IOL chamber 104 captures the IOL 10 and precludesexiting of the IOL under intended operating parameters. In each of theengaged storage and the engaged loading configuration of the shuttleplates 120, 160, passage of the IOL 10 from the shuttle 100 is inhibitedby the size of the distal and proximal ports 106, 108 and the accessport 150 relative to the size of the IOL (or at least the size of theoptic 16 of the IOL).

The shuttle 100 carrying the retained IOL 10 is then engaged with thevial 200. Upon engagement of the shuttle 100 with the vial 200, theorienting surfaces 210 of the vial contact select exposed surfaces ofthe shuttle to orient the shuttle in the vial.

The locating surfaces 220 of the vial 200 project into the IOL chamber104 for locating the IOL 10 within the shuttle 100, as seen in FIGS.5-7. Thus, the IOL 10 is at least partly located within the IOL chamber104 by surfaces in addition to the surfaces of the engaged shuttleplates 120, 160 that define the IOL chamber.

The wedging surfaces 230 of the vial 200 contact the shuttle plates 120,160 to dispose the shuttle 100 in the storage configuration. That is,the wedging surfaces 230 contact surfaces 150 on both shuttle plates andimpart or ensure the loading set of confronting surfaces 124, 164 arespaced apart, such that the IOL chamber 104 does not bend or fold theIOL 10. Thus, the storage set of confronting surfaces 122, 162 remain inan abutting position and the loading confronting surfaces 124, 164 to aspaced or separated position. As seen in FIGS. 5-7, the IOL chamber 104then retains the IOL 10 without any material deformation or stress tothe optic 16 of the IOL, such that the optic is in a nominal state andin select embodiments without any material deformation or stress to theoptic and the haptics 12, 14.

The distal port 106 and the proximal port 108 having a smaller dimensionthan the IOL 10 (or at least the optic 16 of the IOL) preclude passageof the IOL from the IOL chamber 104 through the ports. Similarly, theaccess port 150 has a dimension to preclude passage of the IOL 10 underintended operating parameters. Absent an external removal force, such asthe plunger acting on the IOL 10, the IOL chamber 104 retains the IOLwithin the chamber in both the engaged storage configuration of theshuttle (the engaged first and second shuttle plates 120, 160) and theengaged loading configuration of the shuttle (the engaged first andsecond shuttle plates).

Thus, as the shuttle 100 is engaged with the vial 200, the storage setof confronting surfaces 122, 162 are abutting; the loading set ofconfronting surfaces 124, 164 are spaced apart. The orienting surfaces210 of the vial 200 contact the outer surfaces of the shuttle 100 toposition and retain the shuttle within the vial. The wedging surfaces230 of the vial 200 contact the surfaces 150 of the shuttle 100 tomaintain the loading set of confronting surfaces 124, 164 in the nominalspaced apart relation to dispose the shuttle in the storageconfiguration and the locating surfaces 220 of the vial 200 project intothe IOL chamber 104 and limit movement or contact a periphery of the IOL10 and locate the IOL within the IOL chamber.

The loaded shuttle 100 is retained in the vial 200, sterilized andpackaged with a volume of sterile solution. As the IOL 10 is in anunstressed, nominal state, the only limitation on the duration of thestorage is the duration of the sterile conditions/packaging.

For presenting the IOL 10 to the patient, the lid 202 is removed fromthe vial 200, thereby exposing the shuttle 100 as it is retained in thevial. The shuttle 100 is disengaged from the vial 200.

The shuttle 100 is then engaged with the injector 300 by engaging theretaining tabs 128, 168 of the shuttle with the engaging surfaces 332 ofthe injector. The engaging surfaces 332 or camming surfaces 334 canfunction as alignment surfaces of the injector 300 and contactcorresponding surfaces of the shuttle 100 to operably locate the shuttle100 in the injector. The camming surfaces 334 are configured to disposethe shuttle 100 in the loading configuration, wherein the loading set ofconfronting surfaces 124, 164 are flexed or pivoted about the flexureinterface and both the storage set of confronting surfaces 122, 162 andthe loading set of confronting surfaces 124, 164 abut as seen in FIGS.11 and 15.

In the loading configuration, the IOL chamber 104 defines a reduceddimension for the optic 16 of the IOL 10, thereby imparting apredetermined bend or curvature to the IOL, as seen in FIGS. 11-16. Asset forth below, the predetermined bend or curvature to the IOL 10,ensures that the IOL does not move forward along the shuttle lumen 102toward the patient eye until the IOL is contacted by the plunger tip344, which in turn allows the plunger tip to contact the trailing haptic14 and in conjunction with the corresponding haptic ramp and fold thehaptic over the optic 16.

To dispense the IOL 10 from the injector 300, the plunger 340 isactuated causing the plunger tip 344 to enter the shuttle lumen 102 andthe IOL chamber 104. The predetermined bend in the optic 16 of the IOL10 retards movement of the IOL along the shuttle lumen 102. Thus, as theplunger tip 344 first contacts the IOL 10 and specifically the trailinghaptic 14, the trailing haptic begins to contact the correspondinghaptic ramp and fold over the optic 16. Continued contact by the plungertip 344 and resistance from the curvature of the optic 16 pushes thetrailing haptic 14 up the haptic ramp and folds the trailing haptic overthe optic such that the plunger tip then contacts the periphery of theoptic. Upon continued contact of the plunger tip 344 and the IOL 10 asthe plunger tip advances along the shuttle lumen 102, the leading haptic12 moves up the corresponding haptic ramp to be disposed above the optic16.

As the plunger 340 continues to move the IOL 10 along the longitudinalaxis and the shuttle lumen 102, the optic 16 of the IOL 10 continues todeform or bend in the direction imparted by the transition of theshuttle 100 from the storage configuration to the loading configuration,and each of the leading and trailing haptics 12, 14 moves up along therespective haptic ramps 132, 172 to dispose a majority of each haptic inan overlying position with respect to the optic.

The plunger 340 continues to move the IOL 10 along the shuttle lumen 102passing from the shuttle 100 and to the injector tip 320, whereby theIOL can be further deformed to an insertion configuration forpresentation to the eye.

Thus, the present shuttle 100 provides for releasably engaging orretaining the IOL 10, wherein the shuttle includes a first component,such as the first shuttle plate 120 and an independent second component,such as the second shuttle plate 160 wherein the first component and thesecond component define a first set of confronting surfaces and a secondset of confronting surfaces and are configured to operably engage so asto define a shuttle lumen 102 extending along the longitudinal axis, theshuttle lumen having the IOL chamber 104 bounded by the proximal port108 and the distal port 106 on the longitudinal axis; and the operableengagement of the first component and the second component providing (i)a first configuration of the IOL chamber and (ii) a second configurationof the IOL chamber by selectively flexing or pivoting a portion of theengaged shuttle plates about a flexure interface to simultaneouslycontact the first set of confronting surfaces and the second set ofconfronting surfaces.

It is contemplated a center line of the optic 16 of the IOL 10 can belocated along the longitudinal axis, upon the first shuttle plate 120and the second shuttle plate 160 being in the first configuration. Thatis, a midpoint of the optic 16 of the IOL 10 retained within the IOLchamber 104 lies on the longitudinal axis of the lumen. However, it isunderstood that based on the specific structure of the IOL chamber 104,the midpoint of the optic 16 can be above or below a horizontal planeencompassing the longitudinal axis.

Having thus described the inventive concepts and a number of exemplaryembodiments, it will be apparent to those skilled in the art that theinvention may be implemented in various ways, and that modifications andimprovements will readily occur to such persons. Thus, the embodimentsare not intended to be limiting and presented by way of example only.The invention is limited only as required by the following claims andequivalents thereto.

1. A shuttle for retaining an IOL having an optic, the shuttle comprising: (a) a first shuttle plate and a separate second shuttle plate operably coupled and configurable between a coupled storage configuration and a coupled loading configuration, the first and the second shuttle plates in each of the coupled storage configuration and the coupled loading configurations defining an IOL chamber extending along a longitudinal axis, the IOL chamber axially bounded by a proximal port and a distal port, wherein each of the proximal port and the distal port in each of the coupled storage configuration and the coupled loading configurations has a major dimension transverse to the longitudinal axis, the major dimension being smaller than a diameter of the optic.
 2. The shuttle of claim 1, wherein at least one of the first shuttle plate and the second shuttle plate flexes about a flexure interface to move the operably coupled first and second shuttle plates from the coupled storage configuration to the coupled loading configuration.
 3. The shuttle of claim 1, wherein the IOL chamber has a storage configuration when the first and the second shuttle plates are in the coupled storage configuration and a loading configuration when the first and the second shuttle plates are in the coupled loading configuration.
 4. The shuttle assembly of claim 3, wherein the storage configuration of the IOL chamber does not deform the optic of the IOL from a nominal formation.
 5. The shuttle assembly of claim 3, wherein the loading configuration of the IOL chamber deforms the optic of the IOL from a nominal formation to a preferential curvature.
 6. The shuttle of claim 1, wherein the IOL chamber in each of the coupled storage configuration and the coupled loading configuration of the shuttle captures an IOL.
 7. The shuttle of claim 1, wherein the operably coupled first shuttle plate and the second shuttle plate preclude non-destructive separation.
 8. The shuttle of claim 1, wherein the IOL chamber is coaxial with a longitudinal axis.
 9. The shuttle of claim 1, further comprising a haptic ramp on each of the first and the second shuttle plate, wherein each haptic ramp is sized to displace a haptic to an overlying position with respect to the optic of the IOL.
 10. A shuttle for retaining an IOL having an optic, the shuttle comprising: (a) a first shuttle plate; and (b) a separate second shuttle plate configured to operably engage the first shuttle plate, such that the operably engaged first and second shuttle plates are configured to be disposed between an engaged storage configuration and an engaged loading configuration; wherein the operably engaged first and second shuttle plates define a shuttle having (i) a shuttle lumen extending along a longitudinal axis, the shuttle lumen having an IOL chamber sized to retain an optic of an IOL, (ii) a storage set of confronting surfaces, (iii) a loading set of confronting surfaces and (iv) a flexure interface intermediate the storage set of confronting surfaces and the loading set of confronting surfaces, wherein the operably engaged first and second shuttle plates abut the storage set of confronting surfaces in each of the engaged storage configuration and the engaged loading configuration, and the loading set of confronting surfaces flex from being spaced apart in the engaged storage configuration of the operably engaged first and second shuttle plates to abutting in the engaged loading configuration of the operably engaged first and second shuttle plates.
 11. The IOL shuttle assembly of claim 10, wherein the flexure interface is linear.
 12. The IOL shuttle assembly of claim 10, wherein the first shuttle plate includes a first haptic ramp and the second shuttle plate includes a second haptic ramp.
 13. The IOL shuttle assembly of claim 10, further comprising a vial configured to releasably retain the shuttle in the engaged storage configuration.
 14. The IOL shuttle assembly of claim 10, wherein the IOL chamber defines (i) a storage dimension for the optic of the IOL in the storage configuration and (ii) a loading dimension for the optic of the IOL in the loading configuration, wherein the loading dimension is smaller than the storage dimension.
 15. The IOL shuttle assembly of claim 10, wherein the IOL chamber is axially bounded by a proximal port and a longitudinally spaced distal port, and includes an access port.
 16. The IOL shuttle assembly of claim 10, wherein the IOL chamber and the flexure interface are intermediate the storage set of confronting surfaces and the loading set of confronting surfaces along a direction transverse to the longitudinal axis.
 17. A method of disposing an IOL having an optic within a shuttle, the method comprising: (a) capturing an IOL while located on a fixture within an IOL chamber defined by an engaged first shuttle plate and second shuttle plate, the engaged first shuttle plate and a second shuttle plate defining a shuttle; and (b) withdrawing the fixture from the IOL through a port in the IOL chamber to retain the IOL within the IOL chamber defined by the engaged first shuttle plate and second shuttle plate.
 18. The method of claim 17, further comprising retaining the IOL in a nominal state within the IOL chamber.
 19. The method of claim 17, further comprising engaging the shuttle with a vial, wherein the vial includes surfaces for disposing the first shuttle plate relative to the second shuttle plate in an engaged storage configuration, wherein the IOL is retained in a nominal state within the IOL chamber. 